NCT04160351

A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis

A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Selayang Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.

Detailed description

This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis. Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.

Conditions

• Hemodialysis-Associated Amyloidosis
• Dialysis Amyloidosis
• Quality of Life

Interventions

Type	Name	Description
DEVICE	Theranova 400	medium cut-off dialyser
DEVICE	Elisio-19H	high flux dialyser

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-06-01
• Completion: 2021-12-31
• First posted: 2019-11-13
• Last updated: 2022-05-19

Locations

1 site across 1 country: Malaysia